Lawsuit filed against FDA over inaction on banning menthol cigarettes
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Key takeaways:
- The final rule prohibiting the use of menthol in cigarettes was expected in March 2024, but nothing was issued during that month.
- Three groups against smoking are suing the FDA over the delayed ruling.
Three health groups have filed a lawsuit against the FDA over a delay in finalizing the proposed rule banning menthol cigarettes, according to a press release from one of the groups.
This marks the second lawsuit that the African American Tobacco Control Leadership Council (AATCLC), Action on Smoking and Health (ASH) and the National Medical Association (NMA) have collectively filed against the FDA, according to the release from ASH.
As Healio previously reported, the FDA was expected to have a finalized rule prohibiting the use of menthol in cigarettes back in August 2023, but nothing was issued at that time. The new final rule date was set for March 2024, which again passed with no action from the FDA.
“The FDA has exceeded several of their own self-determined deadlines, including the most recent one of March 2024 for the final rule to be announced,” Kelsey Romeo-Stuppy, BA, JD, managing attorney of ASH, told Healio. “Lives are being lost; the plaintiffs did not feel that we could wait any longer for this public health action.”
In the initial proposal for this ban in April 2022, the FDA said it was based on science and evidence establishing the addictiveness and harm of combusted tobacco products and built on the 2009 Family Smoking Prevention and Tobacco Control Act that prohibits all flavors, other than tobacco and menthol, in cigarettes.
According to the FDA, this ruling is expected to reduce current smoking and smoking-related deaths. However, the delay of the ruling has led to more individuals picking up smoking and dying because of it, Romeo-Stuppy said.
“Approximately 40,000 Americans have died from menthol cigarettes since our first lawsuit was filed in 2020,” Romeo-Stuppy said. “In addition, more people are becoming victim to the tobacco industry; approximately 116,000 people have started smoking due to menthol since our first lawsuit was filed in 2020.”
This delay is particularly harmful to African American individuals because they experience more unfavorable outcomes due to smoking and are less likely to quit.
“As African American physicians, we are deeply disturbed at the continuing delays in FDA’s finalizing of the ban on menthol cigarettes,” Yolanda Lawson, MD, president of the NMA, said in the ASH release. “Our patients, more than any other group, become disabled and die prematurely due to the continued use of these cigarettes.”
Moving forward, clinicians should know that they are important figures capable of sparking change, Romeo-Stuppy said.
“Clinicians can make public statements of support for our lawsuit or write letters to the White House or the FDA urging them to finalize the rule,” she said. “Clinicians also have the incredibly important task of encouraging people who smoke to quit and supporting them while they do.”
References:
- FDA proposes rules prohibiting menthol cigarettes and flavored cigars to prevent youth initiation, significantly reduce tobacco-related disease and death. https://www.fda.gov/news-events/press-announcements/fda-proposes-rules-prohibiting-menthol-cigarettes-and-flavored-cigars-prevent-youth-initiation. Updated June 27, 2022. Accessed April 8, 2024.
- FDA rule. Tobacco product standard for menthol in cigarettes. Available at: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI60. Accessed April 8, 2024.
Perspective
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The lawsuit filed by ASH, AATCLC and NMA to compel the Biden administration to act to remove menthol cigarettes from the marketplace is a significant action to hopefully advance these lifesaving rules.
As a physician and the chief medical officer for the American Lung Association, I am extremely disappointed that the White House has not finalized the rules to stop the sale of menthol cigarettes and flavored cigars. The science is clear: these rules will save lives. The longer President Biden waits, the more youth and young adults will become addicted to menthol cigarette and the more people we will lose to the death and disease caused by tobacco.
The U.S. Food and Drug Administration’s own findings show that menthol cigarettes are not appropriate for the protection of public health. It is frustrating that the continued delay of the menthol rules compelled our partners to go back to court.
We know that menthol cigarettes make it easier to start smoking and harder to quit. That is why flavors, including menthol, are one of the primary reasons kids and teens start using tobacco products. Close to half of all youth who start to smoke begin with menthol cigarettes, leading to nearly 40% of all youth who smoke using menthol cigarettes.
Menthol cigarettes remain a key factor for tobacco-related death and disease in Black communities. More than 81% of Black individuals in America who smoke use menthol cigarettes, and a study released in 2021 found that menthol cigarettes were responsible for 1.5 million new smokers, 157,000 smoking-related premature deaths and 1.5 million life years lost among Black individuals nationally from 1980 to 2018.
Research shows that ending the sale of menthol cigarettes could result in a significant number of people quitting smoking. In fact, one study estimates almost 1 million people would quit smoking within 17 months of the end of the sale of menthol cigarettes.
We at the American Lung Association urge President Biden to finalize these lifesaving rules as soon as possible.
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